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Clinical Trials/NCT06145542
NCT06145542CompletedNot Applicable

Sequences of Aerobic and Resistance Exercise in Training and Their Effects on Cardio-metabolic Functions Among Type 2 Diabetes Patients - a Randomized Study

Zhejiang University1 site in 1 country56 target enrollmentStarted: September 25, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
Fasting Glucose at Baseline

Study Overview

Brief Summary

Aerobic exercise and resistance exercise are two types of exercise commonly used in physical conditioning. Compared to aerobic exercise, a combination of aerobic and resistance exercise has been linked to a greater reduction in hemoglobin A1c (HbA1c) among patients with type 2 diabetes (T2D). However, it is not clear that in a concurrent aerobic-resistance training session, whether the orders of the two types of exercise could act differently in glucose metabolism. This randomized trial aims to investigate the effect of the sequence of exercise modalities (aerobic-resistance vs resistance-aerobic in a training session) on glycemic control among T2D patients following an 8-wk intervention period.

Detailed Description

Objectives:

This randomized study aims to explore the effects of aerobic and resistance training sequences on glycemic control among type 2 diabetes (T2D) patients through an 8-wk combined aerobic and resistance exercise training program.

Study Population:

A total of 56 participants with T2D aged 50-70 years (sex ratio approximately 1:1) with a course of type 2 diabetes of more than one year are included. Participants are residents of Nanjing Municipality, Jiangsu Province, China. Participants are recruited from the outpatients at Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China or through online advertisement published on the official social media (WeChat) channels of the Health Service Center.

Randomization:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 50-70 years;
  • •Type 2 diabetes diagnosed as: random blood glucose ≥11.1mmol/L (200mg/dL) or fasting blood glucose ≥7.0mmol/L (126mg/L) or oral glucose tolerance test (2h) ≥11.1mmol/L (200mg/dL) or glycated hemoglobin (HbA1c) ≥ 6.5%;
  • •The course of type 2 diabetes lasted for one year or longer;
  • •Willing to participate and sign the informed consent form voluntarily

Exclusion Criteria

  • •Type 1 diabetes;
  • •Fasting blood glucose (FBG)>16.7mmol/L;
  • •Severe complications of diabetes such as acute infection, diabetic ketoacidosis, and plantar lesions;
  • •Severe kidney disease, cardiovascular and cerebrovascular diseases as identified by a specialist;
  • •Musculoskeletal, neurological, psychiatric or other disorders which limit the ability to exercise as identified by a specialist;
  • •Doing physical exercise regularly (≥ 3 times per week, at least 1 hour per session of moderate to vigorous activities);
  • •Currently under dietary program for weight loss;
  • •Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at rest;
  • •Abnormal electrocardiogram (rest and exercise);
  • •Other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months

Arms & Interventions

AR group

Experimental

aerobic exercise then resistance exercise in all training sessions

Intervention: AR group: aerobic training before resistance training (Behavioral)

RA group

Active Comparator

resistance exercise then aerobic exercise in all training sessions

Intervention: RA group: resistance exercise before aerobic exercise (Behavioral)

Outcomes

Primary Outcomes

Fasting Glucose at Baseline

Time Frame: At week 0, within 7 days before the intervention starts

blood glucose level following overnight (12-h) fasting

Fasting Glucose at Follow-up

Time Frame: At week 9, within 7 days after the intervention completes

blood glucose level following overnight (12-h) fasting

Hemoglobin A1c (HbA1c) at Baseline

Time Frame: At baseline, within 7 days before the intervention starts

At baseline, the HbA1c level in blood among all participants

Hemoglobin A1c (HbA1c) at Follow-up

Time Frame: At week 9, within 7 days after the completion of the 8-week intervention

After intervention, the HbA1c level in blood among all participants

Continuous Glucose Monitoring at Baseline (Mean, sd, Lage)

Time Frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (mean, sd, lage)

At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Baseline (Coefficient of Variation)

Time Frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (cv)

At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR

Continuous Glucose Monitoring at Baseline (Tir, Tar, Tbr)

Time Frame: At baseline, within 14 days before the intervention starts, measurement lasts for 14 days (tir, tar, tbr)

At baseline, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Follow-up (Mean, sd, Lage)

Time Frame: at week 8-9

After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Continuous Glucose Monitoring at Follow-up (Coefficient of Variation)

Time Frame: at week 8-9

At baseline, 14-day continuous glucose monitoring including mean glucose value, standard deviation (SD) of the glucose values, coefficient of variation (CV) of relative standard deviation, LAGE, TIR, TAR, TBR

Continuous Glucose Monitoring at Follow-up (Tir, Tar, Tbr)

Time Frame: at week 8-9

After intervention, 14-day continuous glucose monitoring including mean, sd, cv, lage, tir, tar, tbr

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Zhejiang University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiao Tan

Associate Professor

Zhejiang University

Study Sites (1)

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